Parallel jaw inserter

ABSTRACT

An interbody system including an implant and a tool for inserting and expanding the medical implant and locking the implant in place is disclosed. The medical implant may include an expandable body defined by a superior endplate and an inferior endplate that are hingedly coupled and may be expanded and lordosed. The superior and inferior endplate may include gripping protrusions that mate and/or directly engage with recessed jaws of disclosed surgical tool. The surgical tool may include a vertically movable jaw to expand and contract the implant when engaged with the gripping protrusions of the implant. The surgical tool may also include a drive portion that engages the drive feature of the lock screw with the drive end of the surgical tool lock the implant while in an expanded position.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation in part of: U.S. patent applicationSer. No. 17/736,523, titled EXPANDABLE IMPLANT AND CORRESPONDINGSURGICAL TOOL, filed May 4, 2022, which is a continuation in part ofU.S. patent application Ser. No. 17/665,449, titled EXPANDABLE IMPLANTAND CORRESPONDING INSERTER, filed Feb. 4, 2022, which is a continuationin part of U.S. patent application Ser. No. 17/515,709, titledEXPANDABLE IMPLANT AND CORRESPONDING INSERTER, filed Nov. 1, 2021, whichis a continuation in part of U.S. patent application Ser. No.17/356,950, titled EXPANDABLE INTERBODY IMPLANT, filed Jun. 24, 2021(now U.S. Pat. No. 11,612,499). The entire disclosure of eachapplication is incorporated herein by reference. This application alsoincorporates by reference U.S. application Ser. No. 17/307,578, titledEXTERNALLY DRIVEN EXPANDABLE INTERBODY AND RELATED METHODS, filed May 5,2021; U.S. Pat. No. 11,096,796, titled INTERBODY SPINAL IMPLANT HAVING AROUGHENED SURFACE TOPOGRAPHY ON ONE OR MORE INTERNAL SURFACES, and filedon Mar. 4, 2013; and U.S. Pat. No. 10,821,000, titled TITANIUM IMPLANTSURFACES FREE FROM ALPHA CASE AND WITH ENHANCED OSTEOINDUCTION, andfiled Jun. 29, 2017.

FIELD

The present technology is generally related to an externally drivenexpandable interbody implant for use in a medical procedure related tothe spine. In some embodiments, disclosed implants may be used in ananterior cervical discectomy and fusion (ACDF) procedure although otheruses in other areas of the spine or between two bones are alsocontemplated.

BACKGROUND

Mechanically operated interbody implants may be used to align and/orrealign a patient's spine during a medical procedure and/or for purposesof fusion, degenerative tissue and/or trauma/repair procedures.Conventional implants designed for the Thoracic and Lumbar region of thespine often include top and bottom endplates and a mechanical means toseparate the top and bottom endplates. The mechanical mechanisms toseparate the top and bottom endplates are often cumbersome and require alarge footprint that is often unsuitable, for example, for ACDF typesurgeries of the cervical portion of the spine.

Many currently available ACDF type implants may be limited in an abilityto optimize the adjustment of lordosis or sagittal alignment of thevertebral bodies because they may rely on a fixed lordotic angle betweenthe superior/cephalad and inferior/caudad faces of the device.

SUMMARY

The techniques of this disclosure generally relate to an expandableinterbody implant including a superior endplate and an inferior endplatehingedly coupled and which may further include a locking element tosecure the inferior endplate and superior endplate in a particularconfiguration, for example. The superior and inferior endplates may bemoved in a multitude of expanded and/or lordosed or kyphosed orotherwise angled configurations via an external inserter, for example.In various embodiments, a locking screw may include a drive feature forengaging with a drive end of a surgical tool. In various embodiments,gripping protrusions on the proximal end of the implant may be used forgripping the implant to insert it into a disc space and afterward theimplant may be expanded by a corresponding drive tool. Additionally, invarious embodiments, the locking screw may also be used to grip andstabilize the implant to insert the implant into a disc space.Additionally, in various embodiments female recesses, rather than tangs(or male bosses or protrusions), may be used for gripping the implantand inserting the implant into a disc space.

In one aspect, the present disclosure provides for an expandable implantmovable between a contracted position (closed position) and an expandedposition, for example. The expandable implant may include an expandablebody extending from a proximal end to a distal end in aproximal-to-distal direction (may also be referred to as ananterior-to-posterior direction depending on surgical technique),extending from a first lateral side to a second lateral side in awidthwise direction, and extending from a superior endplate to aninferior endplate in a heightwise direction (may also be referred to asa cephalad-to-caudal and/or vertical direction depending on surgicaltechnique), for example. In various embodiments, the expandable body maybe defined by a superior endplate and an inferior endplate that arehingedly connected, for example. In various embodiments, the superiorendplate includes a first core having a distal engagement surface (mayalso be referred to as a posterior engagement surface depending onsurgical technique) and the inferior endplate includes a second corehaving a proximal engagement surface (may also be referred to as ananterior engagement surface) and a threaded screw aperture, for example.In various embodiments, disclosed implants may include a locking screw,having a drive feature that may engage with the drive end of a surgicaltool and be movable between a locked position and an unlocked position,for example. In various embodiments, when in the locked position, thelocking screw urges the distal engagement surface of the first core intodirect contact with the proximal engagement surface of the second core,for example. In this way, a surgeon may expand the implant to anappropriate height and angle, and then the superior endplate andinferior endplate may be locked into an angled configuration relative toone another.

In another aspect, the disclosure provides for a system including amedical implant and a surgical tool, for example. The system may includean expandable implant movable between a contracted position and anexpanded position, for example. In various embodiments, the expandedposition may also refer to a distracted and angled orientation of thesuperior endplate and inferior endplate. The expandable implant mayinclude an expandable body extending from a proximal end to a distal endin a proximal-to-distal direction and extending from a first lateralside to a second lateral side in a widthwise direction, for example. Invarious embodiments, the expandable body may be defined by a superiorendplate and an inferior endplate that are hingedly connected, forexample. In various embodiments, the superior endplate includes a firstcore having a distal engagement surface and the inferior endplateincludes a second core having a proximal engagement surface and athreaded screw aperture, for example. In various embodiments, disclosedimplants may include a locking screw that is disposed in the threadedscrew aperture and movable between a locked position and an unlockedposition, for example. In various embodiments, when in the lockedposition, the locking screw urges the distal engagement surface of thefirst core into direct contact with the proximal engagement surface ofthe second core, for example. The system may also include a surgicaltool for expanding the implant and tightening the locking screw whilethe implant is expanded at a desired height, position, and/or angle. Invarious embodiments, the surgical tool may include an inserter portionhaving a rotating and a non-rotating jaws that engages with the grippingprotrusions of the disclosed implant. In some embodiments, actuation ofa cam twist grip of the inserter portion may spread the rotating jaw andnon-rotating jaw apart from one another in a horizontal directionallowing for alignment and engagement with the gripping protrusions. Insome embodiments, a rotating jaw may engage with a gripping protrusionof the superior endplate to move the implant to an expanded position. Insome embodiments, the disclosed surgical tool may include a driveportion configured for insertion in the surgical tool and extendinglongitudinally in a proximal to distal direction of the inserter portionto expand and lock the expandable implant. In various embodiments, theactuation of the rotation knob of the drive portion may spread therotating jaw and non-rotating jaw apart from one another in a verticaldirection thereby pivotally expanding the expandable implant. In variousembodiments, the surgical tool may include at least one angle indicatorto identify respective angle of inclination positions of the implant. Inat least some embodiments, a plurality of angle indicators may beprovided that include respective rotatable dials.

The details of one or more aspects of the disclosure are set forth inthe accompanying drawings and the description below. Other features,objects, and advantages of the techniques described in this disclosurewill be apparent from the description and drawings, and from the claims.

BRIEF DESCRIPTION OF DRAWINGS

FIG. 1 is a perspective view of an expandable implant.

FIG. 2 is an alternate perspective view of an expandable implant.

FIG. 3 is a top down view of an expandable implant.

FIG. 4 is a side view of an expandable implant.

FIG. 5 is a rear perspective view of an expandable implant.

FIG. 6 is a perspective view of the interior of a superior endplate ofan expandable implant.

FIG. 7 is a perspective view of the interior of an inferior endplate ofan expandable implant.

FIG. 8 is a perspective exploded parts view of an expandable implant.

FIG. 9 an exploded parts view of an expandable implant from a side viewperspective.

FIG. 10 is a perspective cross section view of an expandable implant.

FIG. 11 is a cross section view of an expandable implant.

FIG. 12 is a side view of a superior endplate for use with at least someexpandable implant embodiments.

FIG. 13A is a perspective view of a first expandable implant.

FIG. 13B is a perspective view of a second expandable implant.

FIG. 14A is a perspective view of a third expandable implant.

FIG. 14B is a perspective view of a fourth expandable implant.

FIG. 15 is a perspective view of a fifth expandable implant.

FIG. 16 is a side view of an expandable implant in the expandedconfiguration.

FIG. 17 is a side view of an expandable implant showing a bone screwtrajectory.

FIG. 18 is a front view of an expandable implant.

FIG. 19 is a front view of an enlarged area of FIG. 18 .

FIG. 20 is a perspective view of an inserter for use with disclosedexpandable implants.

FIG. 21 is a perspective view of an inserter for use with disclosedexpandable implants shown in skeleton outlining for ease ofunderstanding.

FIG. 22 is a perspective view of an inserter for use with disclosedexpandable implants shown in skeleton outlining for ease ofunderstanding.

FIG. 23A is a rear view of an inserter in a non-expanded position.

FIG. 23B is a rear view of an inserter in an expanded position.

FIG. 24 is an enlarged view of a distal end of an inserter in anexpanded position coupled to an example expandable implant in acorresponding expanded position.

FIG. 25 is a perspective view of an expandable implant in an expandedconfiguration after a breakoff portion of a locking screw has beenbroken off.

FIG. 26 is a perspective view of a surgical instrument for use withdisclosed expandable implants.

FIG. 27 is a perspective view of a surgical instrument for use withdisclosed expandable implants.

FIG. 28 is a perspective view of an expandable implant after themounting tangs have been broken off.

FIG. 29 is a reference drawing showing the human spine of which variousdisclosed implant embodiments may be installed in.

FIG. 30 is a reference drawing showing various planes and referencedirections of which the various disclosed implant embodiments may movein or act in with respect to a patient.

FIG. 31 is a perspective view of a second implant embodiment.

FIG. 32 is a first perspective exploded parts view of the second implantembodiment.

FIG. 33 is a second perspective exploded parts view of the secondimplant embodiment.

FIG. 34 is a side exploded parts view of the second implant embodiment.

FIG. 35 is a first side view of a breakoff screw having a recessedfracture surface.

FIG. 36 is a second side view of a breakoff screw having a recessedfracture surface.

FIG. 37 is a cross section view of a breakoff screw having a recessedfracture surface.

FIG. 38 is a perspective view of a swaging fixture.

FIG. 39 is a cross section view of a swage mandrel and a distal end of abreakoff screw before the commencement of a swage process.

FIG. 40 is a cross section view showing a result of a swage process.

FIG. 41 is an enlarged view of region S-W of FIG. 40 .

FIG. 42A is a front perspective view of a third implant embodiment.

FIG. 42B is an alternate front perspective view of a third implantembodiment.

FIG. 43A is a front perspective view of an implant having angledengagement features.

FIG. 43B is a top down view of an implant having angled engagementfeatures.

FIG. 44 is a perspective view of a surgical tool for use with disclosedimplant embodiments.

FIG. 45 is a first side view of a surgical tool for use with disclosedimplant embodiments.

FIG. 46A is a second side view of a surgical tool for use with disclosedimplant embodiments.

FIG. 46B is a third side view of a surgical tool in an operativeposition for use with disclosed implant embodiments.

FIG. 46C is a perspective view of a surgical tool in the operativeposition.

FIG. 47A is first exploded parts view of a surgical tool for use withdisclosed implant embodiments.

FIG. 47B is second exploded parts view of a surgical tool for use withdisclosed implant embodiments.

FIG. 48 is a perspective view showing a surgical tool immediately priorto coupling with a surgical implant.

FIG. 49 is a first cross section drawing of the surgical tool andimplant in a coupled configuration.

FIG. 50 is a second cross section drawing of the surgical tool andimplant in a coupled configuration.

FIG. 51 is a third cross section drawing of the surgical tool andimplant in a coupled configuration.

FIG. 52 is a perspective view showing a parallel jaw inserter and adrive portion in an assembled configuration.

FIG. 53 is a perspective view showing a parallel jaw inserter and adrive portion disassembled.

FIG. 54 is an exploded parts view of a parallel jaw inserter and a driveportion for use with disclosed implant embodiments.

FIG. 55 is a perspective view of a distal end of a parallel jawinserter.

FIG. 56 is a perspective exploded parts view of a distal end of aparallel jaw inserter.

FIG. 57 is a top-down perspective view showing exploded parts view of adistal end of a parallel jaw inserter.

FIG. 58 is a second perspective exploded parts view of a distal end of aparallel jaw inserter.

FIG. 59 is a first perspective view showing a parallel jaw inserterwithout an outer body assembly.

FIG. 60 is a second perspective view showing a parallel jaw inserterwithout an outer body assembly.

FIG. 61 is a perspective view showing a distal end of a parallel jawinserter with parallel jaw closed and rotating jaw down.

FIG. 62 is a perspective view showing a distal end of a parallel jawinserter with parallel jaw closed and rotating jaw up.

FIG. 63 is a perspective view showing a distal end of a parallel jawinserter with parallel jaw open and rotating jaw down.

FIG. 64 is a perspective view showing a distal end of a parallel jawinserter with parallel jaw open and rotating jaw up.

FIG. 65A is a perspective view showing a proximal end of a driveportion.

FIG. 65B is a perspective view showing a distal end of a parallel jawinserter.

DETAILED DESCRIPTION

Embodiments of the present disclosure relate generally, for example, tospinal stabilization systems, and more particularly, to surgicalinstruments for use with spinal stabilization systems. Embodiments ofthe devices and methods are described below with reference to theFigures.

The following discussion omits or only briefly describes certaincomponents, features and functionality related to medical implants,installation tools, and associated surgical techniques, which areapparent to those of ordinary skill in the art. It is noted that variousembodiments are described in detail with reference to the drawings, inwhich like reference numerals represent like parts and assembliesthroughout the several views, where possible. Reference to variousembodiments does not limit the scope of the claims appended heretobecause the embodiments are examples of the inventive concepts describedherein. Additionally, any example(s) set forth in this specification areintended to be non-limiting and set forth some of the many possibleembodiments applicable to the appended claims. Further, particularfeatures described herein can be used in combination with otherdescribed features in each of the various possible combinations andpermutations unless the context or other statements clearly indicateotherwise.

Terms such as “same,” “equal,” “planar,” “coplanar,” “parallel,”“perpendicular,” etc. as used herein are intended to encompass a meaningof exactly the same while also including variations that may occur, forexample, due to manufacturing processes. The term “substantially” may beused herein to emphasize this meaning, particularly when the describedembodiment has the same or nearly the same functionality orcharacteristic, unless the context or other statements clearly indicateotherwise. The term “about” may also be used herein to emphasize thismeaning and if a value and/or a range of values is provided in thespecification or claims with the modifier “about” a meaning of +/−tenpercent (10%) to those provided values are encompassed by the meaning of“about,” unless the context clearly indicates otherwise.

Referring to FIGS. 1-43 generally, various embodiments and views of anexpandable implant 100 are disclosed. The components of expandableimplant 100 can be fabricated from biologically acceptable materialssuitable for medical applications, including metals, synthetic polymers,ceramics and bone material and/or their composites. For example, thecomponents, individually or collectively, can be fabricated frommaterials such as stainless steel alloys, commercially pure titanium,titanium alloys, Grade 5 titanium, super-elastic titanium alloys,cobalt-chrome alloys, superelastic metallic alloys (e.g., Nitinol, superelasto-plastic metals, such as GUM METAL™), ceramics and compositesthereof such as calcium phosphate (e.g., SKELITE™), thermoplastics suchas polyaryletherketone (PAEK) including polyetheretherketone (PEEK),polyetherketoneketone (PEKK) and polyetherketone (PEK), carbon-PEEKcomposites, PEEK-BaSO4 polymeric rubbers, polyethylene terephthalate(PET), fabric, silicone, polyurethane, silicone-polyurethane copolymers,polymeric rubbers, polyolefin rubbers, hydrogels, semi-rigid and rigidmaterials, elastomers, rubbers, thermoplastic elastomers, thermosetelastomers, elastomeric composites, rigid polymers includingpolyphenylene, polyamide, polyimide, polyetherimide, polyethylene,epoxy, bone material including autograft, allograft, xenograft ortransgenic cortical and/or corticocancellous bone, and tissue growth ordifferentiation factors, partially resorbable materials, such as, forexample, composites of metals and calcium-based ceramics, composites ofPEEK and calcium based ceramics, composites of PEEK with resorbablepolymers, totally resorbable materials, such as, for example, calciumbased ceramics such as calcium phosphate, tri-calcium phosphate (TCP),hydroxyapatite (HA)-TCP, calcium sulfate, or other resorbable polymerssuch as polyaetide, polyglycolide, polytyrosine carbonate,polycaroplaetohe, polylactic acid or polylactide and their combinations.

In various embodiments, components may be coated with a ceramic,titanium, and/or other biocompatible material to provide surfacetexturing at (a) the macro scale, (b) the micro scale, and/or (c) thenano scale, for example. Similarly, components may undergo a subtractivemanufacturing process providing for surface texturing configured tofacilitate osseointegration and cellular attachment and osteoblastmaturation. Example surface texturing of additive and subtractivemanufacturing processes may comprise (a) macro-scale structural featureshaving a maximum peak-to-valley height of about 40 microns to about 500microns, (b) micro-scale structural features having a maximumpeak-to-valley height of about 2 microns to about 40 microns, and/or (c)nano-scale structural features having a maximum peak-to-valley height ofabout 0.05 microns to about 5 microns. In various embodiments, the threetypes of structural features may be overlapping with one another, forexample. Additionally, such surface texturing may be applied to anysurface, e.g., both external exposed facing surfaces of components andinternal non exposed surfaces of components. Further discussionregarding relevant surface texturing and coatings is described in, forexample, U.S. Pat. No. 11,096,796, titled Interbody spinal implanthaving a roughened surface topography on one or more internal surfaces,and filed on Mar. 4, 2013—the entire disclosure of which is incorporatedherein by reference in its entirety. Accordingly, it shall be understoodthat any of the described coating and texturing processes of U.S. Pat.No. 11,096,796, may be applied to any component of the variousembodiments disclosed herein, e.g., the exposed surfaces and internalsurfaces of endplates. Another example technique for manufacturing anorthopedic implant having surfaces with osteoinducting roughnessfeatures including micro-scale structures and nano-scale structures isdisclosed in U.S. Pat. No. 10,821,000, the entire contents of which areincorporated herein by reference. Additionally, an example of acommercially available product may be the Adaptix™ Interbody System soldby Medtronic Spine and comprising a titanium cage made with TitannanoLOCK™.

Referring generally to FIGS. 1-5 various views of an expandable implant100 in a collapsed position are illustrated. FIGS. 1-2 are variousperspective views of an expandable implant 100. FIG. 3 is a top downview of an expandable implant 100. In the example embodiment, expandableimplant 100 may include a proximal end 100P, a distal end 100D, andfirst and second lateral sides 100L. Additionally, a pair of bone screwapertures 11, 21 may be positioned on the proximal end 100P, forexample. In various embodiments, bone screw apertures 11, 21 maycomprise a corresponding bone screw retention mechanism 11 a, 21 a (mayalso be referred to as an anti-backout locking mechanism). In theexample embodiment, the bone screw retention mechanisms 11 a, 21 a,comprise a flexible tang member having a hook portion at an end thereofthat allows the flexible tang member to flex outward in a lateraldirection away from the corresponding bone screw aperture 11, 21 duringinitial installation of the bone screw and to flex back inward towardsthe corresponding bone screw aperture 11, 21 to prevent a correspondingbone screw from backing out. For example, as the bone is installed inbone screw aperture 11, 21, the bone screw retention mechanism 11 a, 21a, may flex outward as the underside of the head portion contactsinclined surface 11 c (see FIG. 19 ).

In various embodiments, and as illustrated in FIGS. 1-2 , mounting tangs19, 29 may extend in a proximal direction (may also be referred to as ananterior direction depending on surgical technique and orientation), forexample. In various embodiments, implant 100 may be referred to as anexternally driven expandable implant because an end user or surgeon mayuse a surgical tool to open and close implant 100, e.g. expand implant100. For example, an external tool may adjust the lordotic angle ofimplant 100 as will be explained in detail with respect to FIGS. 20-25 .Once implant 100 is expanded to an appropriate lordotic angle (alsoreferred to as angle of inclination), an end user may fix the relativeangle of the superior endplate 10 relative to the inferior endplate 20by tightening locking screw 50, for example. In some embodiments,superior endplate 10 may be referred to as a “cephalad” endplate andinferior endplate 20 may be referred to as a “caudal” endplate.

Locking screw 50 may also be used in other embodiments, such as fixationof posterior rods, fixation of pedicle screws, and other set screwconstructs. Additionally, locking screw 50 may be referred to as a“breakoff screw” in some embodiments.

At least one advantage of relying on an external tool to adjust alordotic angle of implant 100 may be the reduction of internalcomponents within implant 100 relative to other forms of implantsrelying on various moving mechanisms and/or expansion mechanisms, forexample. Accordingly, in various embodiments, implant 100 may have arelatively large void space in the interior thereof, which mayfacilitate a fusion process during an ACDF procedure. For example,implant 100 may have a relatively large internal volume 101 that is openthrough the superior endplate 10 and inferior endplate 20 which may bepacked with bone graft material, for example.

As illustrated in FIG. 3 , implant 100 may extend in aproximal-to-distal direction (may also referred to as a longitudinaldirection and/or an anterior-to-posterior direction depending onsurgical technique and final orientation) from the proximal end 100P(may be referred to as anterior end depending on surgical technique andfinal orientation) to the distal end 100D (may be referred to asposterior end depending on surgical technique and final orientation)though axis P-D through the center of the implant 100, for example.Implant 100 may extend in a widthwise direction (also referred to aslateral direction) from the first lateral side 100L to the secondlateral side 100L through axis W-W through the center of the implant 100and the center of locking screw 50, for example. The axis P-D may beperpendicular and/or substantially perpendicular to the axis W-W. Forexample, the proximal-to-distal direction may be perpendicular to thewidthwise direction. Additionally, a width of the implant may taper froma proximal end 100P where it is widest towards a distal end 100D whereit is narrowest. In various embodiments, implant 100 may extend from asuperior endplate 10 to an inferior endplate 20 in a heightwisedirection (may also be referred to as a cephalad-to-caudal and/orvertical direction depending on surgical technique and finalorientation).

FIG. 4 is a side view of an expandable implant 100. In the exampleillustration, it is shown that a superior endplate 10 is connected to aninferior endplate 20 such that the superior endplate may pivot about ahinge member 40. In the example embodiment, hinge member 40 comprises anarcuate rail portion of inferior endplate 20 that extends in thewidthwise direction, for example. In other embodiments, the hinge member40 may be reversed relative to the superior and inferior endplates thanas illustrated in FIG. 4 . In the example embodiment, hinge member 40may be nested into a corresponding arcuate cavity of the superiorendplate 10 such that superior endplate 10 may expand and/or otherwiserotate about hinge member 40. Additionally, in various embodiments thesuperior endplate 10 and/or inferior endplate 20 may include variousengagement elements 14 for engaging with an adjacent boney structuresuch as a vertebrae, for example. In the example embodiment, theengagement elements comprise a series of alternating rails and valleystherebetween that extend in the widthwise direction. In someembodiments, the valleys may be angled about 20-40 degrees and in atleast one embodiment the valleys may be angled at about 30 degreesrelative to the corresponding rail (see FIGS. 42A and 42B). At least oneadvantage of this orientation may be a relatively greater resistanceand/or suppression of expulsion of the implant 100 in both the lateraldirection and in the proximal-to-distal direction. However, claws,hooks, dimples, spikes, etc. are also contemplated as example engagementelements 14. In some embodiments, an acid etching process may beutilized to form a roughened or textured surface to facilitate securingthe implant between boney portions and/or suppressing expulsion ofimplant 100.

FIG. 5 is a rear perspective view of an expandable implant 100. In theexample illustration it is shown that the distal end 100D is narrowerthan the proximal end 100P. FIG. 6 is a perspective view of the interiorof a superior endplate 10. In the example illustration, it is shown thatthe distal end of superior endplate 10 includes an arcuate channel 12 ofwhich the hinge member 40 may be disposed inside of. The proximal end ofsuperior endplate 10 may include a bone screw aperture cutout 21 b toallow a relief area for a corresponding bone screw to be insert throughbone screw aperture 21 of inferior endplate 20, for example. Superiorendplate 10 may also include a core 15 comprising an aperture 15 a thatextends from a proximal surface 15 p thereof to a distal surface 15 dthereof, for example. In various embodiments, aperture 15 a may bereferred to as a “slot′” or “screw slot”. In some embodiments, core 15may be referred to as a support frame and take a generally rectangularshape. In various embodiments, the distal surface 15 d may be curved andgenerally face the distal end 100D of implant 100. FIG. 7 is aperspective view of the interior of an inferior endplate 20. In theexample illustration, it is shown that the distal end of inferiorendplate 20 includes a hinge member 40 in the form of an arcuate railthat may be disposed inside of the arcuate channel 12 of the superiorendplate 10, for example. The proximal end of inferior endplate 20 mayinclude a bone screw aperture cutout 11 b to allow a relief area for acorresponding bone screw to be insert through bone screw aperture 11 ofsuperior endplate 10, for example. Inferior endplate 20 may also includea core 25 comprising a threaded aperture 25 a that extends from aproximal surface 25 p thereof to a distal surface 25 d thereof, forexample. In some embodiments, core 25 may be referred to as a supportframe and take a generally rectangular shape. In various embodiments,the superior endplate 10 and inferior endplate 20 may each be formed bya unitary single piece, respectively.

FIG. 8 is a perspective exploded parts view and FIG. 9 is an explodedparts view from a side view perspective of an expandable implant 100. Inthe example embodiment, a locking screw 50 is illustrated. Locking screw50 may include an external thread pattern 51 on an outsidecircumferential surface thereof, for example. The external threadpattern 51 of locking screw 50 may have a size and shape generallycorresponding to the threaded aperture 25 a of core 25 of inferiorendplate 20, for example. In various embodiments, an engagement surface54 may be disposed adjacent and proximal of external thread pattern 51.In the example embodiment, engagement surface 54 is shaped like a washerand is directly connected to locking screw 50. However, in otherembodiments, engagement surface 54 may be a washer or separated element,for example. In some embodiments, engagement surface 54 may be conicallyshaped and/or spherically shaped. Engagement surface 54 may include arelatively planar and/or flat distal surface and/or proximal surface(anterior/ventral surface). In various embodiments, a proximal end ofset screw 50 may include an aperture having an internal threaded surface52. For example, a cylindrical shaped proximal end may include anaperture having a thread pattern disposed on an internal circumferentialsurface of the cylindrical shaped proximal end. In the exampleembodiment, a first drive feature 53 a and a second drive feature 53 bmay be disposed adjacent to and distally with respect to a proximal mostend of set screw 50. Additionally, first and second drive features 53 a,53 b may be disposed proximally with respect to engagement surface 54.In the example embodiment, drive features 53 a, 53 b take a hexalobularshape, although various other shapes such as hexagonal, polygonal, Torx,etc. are also contemplated. In some embodiments, a surgical drive toolhaving a corresponding socket may be coupled to drive features 53 a, 53b to cause rotation of locking screw 50. Similarly, in some alternativeembodiments, a drive tool with a protruding threaded member having athread pattern with a corresponding size and shape to internal threadedsurface 52 may also cause rotation of set screw 50.

As seen best in FIG. 9 , set screw 50 may also include a breakofflocation 55, for example. In the example embodiment, breakoff location55 is disposed directly between drive features 53 a, 53 b and isdesigned to shear off when a sufficient rotational force (torque) isapplied to a proximal end of set screw 50 while a distal end of setscrew 50 is stationary, e.g., when set screw 50 is secured in a lockedposition and a continued rotational force (torque) is applied to theproximal end of set screw 50 the drive feature 53 a and cylindrical endhaving the internal threaded surface 52 may breakoff. In variousembodiments, the internal threaded surface 52 may also be utilized toensure that the broken off portion is removed from the patient andremains connected to a surgical tool/breakoff tool. As also seen best inFIG. 9 , the inferior endplate 20 may include a first relief 40 a and asecond relief 40 b on opposite sides of hinge member 40. The firstrelief 40 a may have a size and shape corresponding to a size and shapeof a first portion 12 a of superior endplate 10 and the second relief 40b may have a size and shape corresponding to a size and shape of asecond portion 12 b of superior endplate 10, for example. In variousembodiments, portions 12 a, 12 b may comprise a hook shape, outdent,and/or protrusion, for example. In the example embodiment, portions 12a, 12 b may be disposed on opposite sides of channel 12 and cup hingemember 40 such that the superior endplate 10 and inferior endplate 20may rotate relative to one another without becoming uncoupled.

FIG. 10 is a perspective cross section view and FIG. 11 is a crosssection view of expandable implant 100. In the example embodiment, thesuperior endplate 10 and inferior endplate 20 are coupled together byhinge member 40, and core 25 may be positioned behind of core 15, e.g.,core 25 may be positioned distally with respect to core 15.Additionally, the outside external thread pattern 51 of locking screw 50may engage with the threaded aperture 25 a of the core 25 and extendthrough aperture 15 a of core 15. In this way, when locking screw 50 isrotated, the distal surface 15 d of core 15 may engage with the proximalsurface 25 p of core 25. For example, by tightening locking screw 50 theengagement surface 54 of locking screw 50 pushes against the proximalsurface 15 p of core 15 thereby bringing the superior endplate 10 andinferior endplate 20 into frictional engagement.

FIG. 12 is a side view of a superior endplate 10 for use with at leastsome expandable implant 100 embodiments. In the example embodiment,superior endplate 10 may include an arcuate channel 12 of which thehinge member 40 may be disposed inside of. In various embodiments,arcuate channel 12 may be defined by a first circle having a centerpoint at P₁ and/or a segment of the circle having the center point atP₁. The center point P₁ may define an axis of rotation that superiorendplate 10 may rotate and/or pivot with respect to inferior endplate20. For example, superior endplate 10 may be hingedly coupled to hingemember 40 as explained above and rotatable about an axis of rotationdefined by center point P₁, for example. Additionally, in variousembodiments a distal surface 15 d of core 15 may be a curved surfacedefined (in part or in total) by a second circle having a center pointat P₁ and a radius R₁. The proximal surface 15 p of core 15 may also bea curved surface defined (in part or in total) by a segment of a circlehaving a radius R₂ and a center point P₂. In the example embodiment, P₂is located a distance D₁ above point P₁ and radius R₂ is greater thanradius R₁. Additionally, the proximal surface 15 p of core 15 is offseta distance D₂ from the proximal most face of the superior endplate 10.In the example embodiment, center point P₂ is vertically above centerpoint P₁ however, in other embodiments, center point P₂ may be offset bya greater amount or even a lesser amount than illustrated. In someexamples, P₂ may not be aligned vertically above P₁. In variousembodiments, R₁ may be about 7-9 mm+/−about 1 mm and R₂ may be about8-10 mm+/−about 1 mm although these numbers may be modified in someembodiments having a larger or smaller footprint. In various embodimentsD₁ is about 0.25 mm to about 1.0 mm and D₂ is about 0.25 mm to about1.25 mm. In at least one embodiment, D₁ is about 0.75 mm and D₂ is about0.8 mm and R₂ is about 9.2 mm.

The above explained geometrical relationship between the offset centerpoints P₁ and P₂ and R₁ and R₂ may have several advantages in terms ofoperability and functionality. At least one advantage is that thesuperior endplate 10 may have a natural tendency to apply a forceagainst the engagement surface 54 of locking screw 50 such that lockingscrew 50 may function similar to a wedge preventing implant 100 fromfully collapsing. Another advantage is that a biasing force may beapplied that naturally urges the superior endplate 10 and inferiorendplate 20 into an expanded position which may assist with expandingthe implant 100 when positioned between a superior vertebrae and aninferior vertebrae, for example. For example still, an end user such asa surgeon may expand implant 100 and the offset arrangement explainedabove may facilitate the function of keeping implant 100 lordosed at thechosen angle.

FIG. 13A is a perspective view of a first expandable implant, FIG. 13Bis a perspective view of a second expandable implant, FIG. 14A is aperspective view of a third expandable implant, FIG. 14B is aperspective view of a fourth expandable implant, and FIG. 15 is aperspective view of a fifth expandable implant. In the series ofillustrations it is shown that various embodiments in accordance withthe principles of this disclosure may be variously sized depending onthe particular location in a human body and the particular patientspecific human anatomy. For example, FIG. 13A illustrates a firstexpandable implant 100 having a first height H₁ or thickness between thesuperior endplate 10 and inferior endplate 20, FIG. 13B illustrates asecond expandable implant 100 having a second height H₂ or thickness,FIG. 14A illustrates a third expandable implant 100 having a thirdheight H₃ or thickness, FIG. 14B illustrates a fourth expandable implant100 having a fourth height H₄ or thickness, and FIG. 15 illustrates afifth expandable implant 100 having a fifth height H₅ or thickness. Inat least some embodiments, H₁ may be about 5 mm, H₂ may be about 6 mm,H₃ may be about 7 mm, H₄ may be about 8 mm, H₅ may about 9 mm, forexample. In various embodiments, an angle of inclination between thesuperior endplate 10 and inferior endplate 20 may be about 4 degrees toabout 15 degrees in an expanded configuration, e.g., an angled and/orinclined configuration.

FIG. 16 is a side view of an expandable implant 100 in the expandedconfiguration. In an expanded position, a distance D₃ between thesuperior endplate 10 and inferior endplate 20 at the proximal end 100Pmay be relatively greater than in the closed configuration, for example.Additionally, an angle of inclination a may be relatively greater in anexpanded position than in the closed configuration, for example. In thisembodiment, implant 100 may have a height H₁ corresponding to FIG. 13Aand be about 5 mm in a closed configuration. In the illustrated expandedconfiguration of FIG. 16 , D₃ may be about 8 mm to 9 mm and a may beabout 10 degrees to about 20 degrees. In at least one embodiment, D₃ maybe 8 mm in a fully expanded position and a may be about 15 degrees, forexample.

FIG. 17 is a side view of an expandable implant 100 showing a bone screwtrajectory 99. In the example embodiment, it is shown that a centeredbone screw trajectory 99 of bone screw 97 is at an angle β with respectto a plane 98 that crosses through a center of the implant from a firstlateral side to a second lateral side, for example. Additionally, thebone screw trajectory 99 may be varied+/− by a degree γ, for example. Invarious embodiments, β may be about 30 degrees to about 50 degrees and γmay be about 2 degrees to about 10 degrees. In the example embodiment, βmay be about 40 degrees and γ may be about 5 degrees.

FIG. 18 is a front view of an expandable implant showing an area A₁ andFIG. 19 is a front view of an enlarged area A₁ of FIG. 18 . In theexample embodiment, bone screw 97 is in a position extending throughbone screw aperture 11 where it cannot backout due to bone screwretention mechanism 11 a. The bone screw retention mechanism 11 aincludes an inclined surface 11 c such that when bone screw 97 is beinginstalled, an underside of the head portion of bone screw 97 directlycontacts the inclined surface 11 c thereby pushing the bone screwretention mechanism 11 a laterally outward and away from bone screwaperture 11, for example. Thereafter, when bone screw 97 is installedand the head portion of bone screw 97 is beneath inclined surface 11 cthe bone screw retention mechanism may flex back towards bone screwaperture 11 such that it will prevent bone screw 97 from backing out,e.g., a blocking surface of bone screw retention mechanism 11 a maycontact an upper surface of the head portion of bone screw 97. In theexample embodiment, bone screw retention mechanism 11 a comprisesflexible arm (or spring tab) having an inclined surface 11 c (or ramp)that is disposed on a lateral end of implant 100 adjacent bone screwaperture 11.

Referring generally to FIGS. 20-24 an inserter 200 for use withdisclosed expandable implants 100 is illustrated. Inserter 200 mayextend in a longitudinal direction from a proximal end 200 p to a distalend 200 d, for example. Inserter 200 may include a pair of handles 230,a handle lock 202, and mounting arms 210 for securely coupling tomounting tangs 19, 29 of implant 100, for example. Inserter 200 mayfurther include a tightening knob 211 that is connected to a drive shaft220 having a drive end 221. Drive end 221 may have a size and shapegenerally corresponding to a size and shape of the various drivefeatures of locking screw 50, for example the internal threaded surface52, first drive feature 53 a, and/or second drive feature 53 b. In theexample embodiment shown in FIG. 24 , drive end 221 includes an endportion having an outside threaded surface with a corresponding size andshape to the internal threaded surface 52 of locking screw 50. Invarious embodiments, tightening knob 211 may rotate drive shaft 220 anddrive end 221 to engage drive end 221 with locking screw 50 and pullimplant 100 towards inserter tool 200 such that mounting tangs 19, 29are securely nested within corresponding channels of mounting arms 210.Additionally, an end user may rotate inserter 200 thereby translating arotational force through drive end 221 to locking screw 50, e.g., viafirst drive feature 53 a, and/or second drive feature 53 b.

As seen best in FIGS. 23A and 23B, inserter 200 may include a pair ofhandles 230, a stationary arm 252, a primary pivoting arm 250, and asecondary pivoting arm 251. For example, to expand implant 100 an enduser may toggle handle lock 202 to an unlocked position and push down onthumb indentation 231 of the handle 230 that is connected to the primarypivoting arm 250 and secondary pivoting arm 251. In doing so, primarypivoting arm 250 may pivot with respect to medial pivot point 240 andsecondary pivoting arm 251 may pivot with respect to distal pivot point245, for example. The path of travel of secondary pivoting arm 251 maylift up on the corresponding mounting tang 19 or 29 and cause thesuperior endplate 10 and inferior endplate 20 to separate from oneanother at the proximal end, for example. In doing so, an end user canlordose implant 100 to a desired angle. For example, as seen best inFIG. 24 , secondary pivoting arm 251 has lifted up on mounting tang 19,which is nested in a corresponding channel of mounting arm 210.

Once implant 100 is lordosed to a desired configuration, an end user mayrotate drive shaft 220 and drive end 221 to tighten locking screw 50 asexplained previously. After locking screw 50 is relatively tight, theend user may continue to apply a rotational force to locking screw 50until a proximal portion comprising the cylindrical part having aninternal threaded surface 52, and the first drive feature 53 a breaksoff at breakoff location 55. For example, once locking screw 50 istightened to a designed torque, the locking screw 50 may shear off asexplained previously. At least one advantage of utilizing the lockingscrew 50, is that it may prevent over tightening which can causedeformation to implant 100. As shown in FIG. 25 , implant 100 has beenexpanded to a desired position and/or lordotic angle. Additionally,locking screw 50 has locked the relative position of the superiorendplate 10 with respect to the inferior endplate 20 and the proximalportion of locking screw 50 has been broken off as explained above.

FIGS. 26 and 27 are various views of a surgical instrument 300 for usewith disclosed expandable implants 100. In some embodiments, surgicalinstrument 300 may be referred to as a breakoff instrument and may beused to breakoff the mounting tangs 19, 29 of implant 100. In theexample embodiment, surgical instrument 300 comprises a first instrument310 and a second instrument 320. First instrument 310 may extend in alongitudinal direction from handle 312 towards gripping end 311.Similarly, second instrument 320 may extend in a longitudinal directionfrom handle 322 to gripping end 321. Gripping ends 311, 321 may comprisea channel having a size and shape generally corresponding to mountingtangs 19, 29. For example, as seen best in FIG. 27 , the mounting tangs19, 29 may be insert inside of the corresponding channels of grippingends 311, 321. After the mounting tangs 19, 29 are nested withingripping ends 311, 321 an end user may push laterally outward and/orinward against handles 312, 322 to breakoff the corresponding mountingtang 19, 29. For example, as shown in FIG. 28 expandable implant 100 isin an expanded and lordosed configuration and the proximal portion oflocking screw 50 and tangs 19, 29 have been broken off.

FIG. 29 is a reference drawing showing the human spine of which variousdisclosed implant embodiments may be installed in. FIG. 30 is areference drawing showing various planes and reference directions ofwhich the various disclosed implant embodiments may move in or act inwith reference to a patient 1.

Referring generally to FIGS. 31-37 a second implant 400 embodiment isdisclosed. Implant 400 may include the same, similar, and/orsubstantially the same components and functionality as explained abovewith respect to implant 100. Accordingly, duplicative description willbe omitted. It shall be understood that various components andfunctionality of implant 100 are readily combinable with implant 400 andvice versa unless the context clearly indicates otherwise.

FIG. 31 is a perspective view of a second implant 400 embodiment. Inthis embodiment, implant 400 extends in a proximal-to-distal directionbetween a proximal end 400P and a distal end 400D and extends in awidth-wise direction between a first lateral end 400L and a secondlateral end 400L. Additionally, implant 400 includes a superior endplate410 and an inferior endplate 420 having substantially similar featuresand functionality as explained above with respect to superior endplate10 and inferior endplate 20 of implant 100, for example. However, inthis embodiment, superior endplate 410 may include a first gripingprotrusion 419 extending in a proximal direction from the proximal end400P of the superior endplate 410. Similarly, inferior endplate 420 mayinclude a second griping protrusion 429 extending in a proximaldirection from the proximal end 400P of the inferior endplate 420. Inthis embodiment, a size and shape of first gripping protrusion 419 issubstantially the same as a size and shape of the second grippingprotrusion 429. However, in other embodiments the first and secondgripping protrusions 419, 429 may be differently sized and shaped, e.g.,to bias the implant towards a surgical instrument and/or orientation forinsertion. In this embodiment, and in the closed position, each grippingprotrusion 419, 429 is disposed at approximately the same distance froman axis of rotation of breakoff set screw 450. In this embodiment,gripping protrusions 419, 429 may replace the need for the tangs 19, 29of implant 100, for example. However, the concepts of utilizing breakofftangs 19, 29 and gripping protrusions 419, 429 are not necessarilymutually exclusive and attributes of one may be combined and/or modifiedin view of the other.

In various embodiments, gripping protrusions 419, 429 may includevarious types of contouring to facilitate grasping of grippingprotrusions 419, 429 with a corresponding inserter, for example surfaceindentations, surface outdents, channeling, etc. In the exampleembodiment, gripping protrusion 419 comprises a superior grippingsurface 419A including an indented portion and an outdented chamferedportion at a proximal most end thereof, for example. Additionally,gripping protrusion 419 comprises an inferior gripping surface 419Bincluding an indented portion and an outdented chamfered portion at aproximal most end thereof, for example. Likewise, gripping protrusion429 comprises a superior gripping surface 429A including an indentedportion and an outdented chamfered portion at a proximal most endthereof, for example. Additionally, gripping protrusion 429 comprises aninferior gripping surface 429B including an indented portion and anoutdented chamfered portion at a proximal most end thereof, for example.In this way, gripping protrusions 419 and 429 are shaped like dovetailsand a corresponding inserter tool may comprise a corresponding shapeddovetail groove which may grasp onto and/or slip over grippingprotrusions 419 and 429 (not illustrated).

Referring generally to FIGS. 32, 33, and 34 various exploded parts viewsof implant 400 are illustrated. FIG. 32 is a first perspective explodedparts view of implant 400, FIG. 33 is a second perspective explodedparts view of implant 400, and FIG. 34 is a side exploded parts view ofimplant 400. In the example embodiment, the superior and inferiorendplates 410, 420 of implant 400 may be hingedly coupled together byhinge member 440 and arcuate channel 412 having similar attributes asexplained above with respect to hinge member 40 and channel 12 ofimplant 100, for example. Additionally, superior endplate 410 may alsoinclude a core 415 having an aperture 415A and inferior endplate 420 mayinclude a core 425 having a threaded aperture 425A having similarattributes to core 15 and core 25 as explained above with respect toimplant 100, for example. In the example embodiment, implant 400utilizes a breakoff screw 450 for locking of a position of the superiorand inferior endplate 410, 420. Breakoff screw 450 may include anexternal thread pattern 451 on an outside circumferential surfacethereof, for example. The external thread pattern 451 of breakoff screw450 may have a size and shape generally corresponding to the threadedaperture 425 a of core 425 of the inferior endplate 420, for example. Invarious embodiments, an engagement surface 454 may be disposed adjacentand proximal of external thread pattern 451. In the example embodiment,engagement surface 454 is shaped like a washer and is directly connectedto breakoff screw 450. However, in other embodiments, engagement surface454 may be a washer or separated element, for example. In someembodiments, engagement surface 454 may be conically shaped. In theexample embodiment, engagement surface 454 may include a relativelyplanar and/or flat distal surface and/or proximal surface.

In various embodiments, a proximal end of breakoff screw 450 may includea first flexible tang 452A and a second flexible tang 452B defining adiscontinuous cylindrical shaped aperture 452 therebetween.Additionally, the first flexible tang 452A and second flexible tang 452Bmay each include an outdent at a proximal end thereof that is shapedlike a segment of an annular ring. In the example embodiment, the firstflexible tang 452A may flex inward towards the second flexible tang 452Bunder loading and vice versa due to the gap between them. At least oneadvantage of this configuration is that it may facilitate securingbreakoff screw 450 to a corresponding drive tool (not illustrated) andthe retention of the broken off part. For example, a drive tool maycomprise a drive end having a female cavity with a corresponding sizeand shape to the drive features 453A, 453B. In various embodiments, thecavity may include a pair of indentations corresponding in size andshape to the outdents of flexible tangs 452A and 452B, for example. Inuse, an end user may align the flexible tangs 452A, 452B with thecavity, push down against the flexible tangs 452A, 452B which may causethem to flex inward towards each other such that they may slide withinthe cavity until the outdents of flexible tangs 45A and 452B are seatedwithin the corresponding indents of the drive tool. Thereafter, an enduser may continue to rotate and or tighten breakoff screw 450. In thisway, after a proximal portion of breakoff screw 450 is broken off it mayremain retained by the inserter due to the flexible tangs 452A and 452Bbeing seated within the corresponding indents.

In some embodiments, aperture 452 may be understood as a cylindricalprotrusion extending in a proximal direction and having a first slit anda second slit extending along the length thereof such that thecylindrical protrusion is compressible. In the example embodiment, afirst drive feature 453A and a second drive feature 453B may be disposedadjacent to and distally with respect to a proximal most end of breakoffscrew 450. Additionally, first and second drive features 453A, 453B maybe disposed proximally with respect to engagement surface 454. Invarious embodiments, a breakoff location may be positioned betweenand/or adjacent to drive features 453A, 453B, which will be explained infurther detail below. In the example embodiment, drive features 453A,453B take a hexalobular shape, although various other shapes such ashexagonal, polygonal, torx, etc. are also contemplated. In someembodiments, a surgical drive tool having a corresponding socket may becoupled to drive features 453A and/or 453B to cause rotation of breakoffscrew 450. Similarly as explained above with respect to locking screw50, once breakoff screw 450 has been sufficiently tightened a proximalportion may breakoff and/or shear off while the distal portion mayremain coupled to implant 400 locking a relative orientation of superiorendplate 410 and inferior endplate 420 in place.

As seen best in FIGS. 35-37 , breakoff screw 450 may extend in alongitudinal direction along a longitudinal axis L-A that is coaxiallyaligned with breakoff screw 450. FIG. 35 is a first side view ofbreakoff screw 450 in which the superior surface 452A and inferiorsurface 452B of discontinuous aperture 452 are visible. FIG. 36 is asecond side view of a breakoff screw 450 that is rotated about 90degrees with respect to FIG. 35 in which only the superior surface 452Ais visible. With reference to FIG. 37 , in various embodiments, breakofflocation 455 may comprise a recessed fracture surface F-S that is insetwith respect to a leading edge (proximal most edge) of drive feature453A. At least one advantage of the recessed fracture surface may bethat delicate tissue is prevented and/or suppressed from coming intocontact with relatively sharp ends of the fracture surface. In theexample illustration, a relative location of the recessed fracturesurface is represented by dashed lines F-S. In the example embodiment,breakoff location 455 may be considered as the boundary between aproximal portion 450A and a distal portion 450B of breakoff screw 450,for example. In this embodiment, the boundary between drive features453A and 453B comprises a necked down portion 458 extending from adistal end of drive feature 453A to an inset portion of drive feature453B that is inset with respect to an outermost and/or proximal mostsurface of drive feature 453B thereby defining a portion of breakoff setscrew 450 having a minimum cross sectional diameter. Accordingly, whenbreakoff screw 450 is sufficiently tightened within threaded aperture425A of core 425 such that the breakoff location 455 experiences asufficient torque the proximal portion 450A may breakoff from the distalportion 450B. For example, when a sufficient rotational force is appliedto the proximal end of breakoff screw 450 while a distal end of breakoffscrew 450 is stationary, i.e., when breakoff screw 450 is secured in alocked position and a continued rotational force (torque) is applied tothe proximal end of breakoff screw 450 the drive feature 453A andcylindrical end having the discontinuous aperture 452 may breakoff. Forfurther explanation in the similar context of implant 100, see FIGS. 10and 11 and the corresponding discussion thereof.

Referring to FIGS. 38-42 an example swaging process is performed to adistal most end of breakoff screw 450. FIG. 38 is a perspective view ofa swaging fixture 500, and FIG. 39 is a cross section view of a swagemandrel and a distal end 450D of a breakoff screw 450 before thecommencement of a swage process. FIG. 40 is a cross section view showinga result of a swage process, and FIG. 41 is an enlarged view of regionS-W of FIG. 40 . In the example embodiment, swaging fixture 500comprises a swaging ram 501 and a swaging mandrel 503 that are supportedby the base of the apparatus. The swaging mandrel 503 may include anoutdent that corresponds to and is slightly larger than the distal mostindent 498 (swage bore) of breakoff screw 450, for example. As seen inregion S-W of FIG. 40 , when swaging mandrel 503 is advanced into thedistal most indent 498 (swage bore) a flared out portion 499 (swagedportion) is formed at a distal most end of breakoff screw 450. Anexample advantage of a swaged end may be that it facilitates retentionof the breakoff screw 450 such that it serves as a stopping structurepreventing breakoff screw 450 from backing out of implant 100.

It shall be understood that although breakoff screw 450 is explainedconcurrently with implant 400 and in the context of an intervertebralimplant, the concepts of breakoff screw 450 may be applied to otherembodiments used for alternate purposes, for example for use in apedicle screw to insert in a tulip to tighten down a rod. It should beunderstood that various aspects disclosed herein may be combined indifferent combinations than the combinations specifically presented inthe description and accompanying drawings. For example, features,functionality, and components from one embodiment may be combined withanother embodiment and vice versa unless the context clearly indicatesotherwise. Similarly, features, functionality, and components may beomitted unless the context clearly indicates otherwise. It should alsobe understood that, depending on the example, certain acts or events ofany of the processes or methods described herein may be performed in adifferent sequence, may be added, merged, or left out altogether (e.g.,all described acts or events may not be necessary to carry out thetechniques).

Referring generally to FIGS. 42-51 , a third implant 400Z and a surgicaltool 600 for use with various implants is disclosed. FIGS. 42A-42Billustrate a third embodiment of an implant 400Z. Implant 400Z may havethe same, similar, and/or substantially the same components andfunctionality as explained above with respect to implant 400, forexample. Accordingly, duplicative description will be omitted. Adifference may be that breakoff screw 450 does not include thediscontinuous cylindrical shaped aperture 452 (see FIG. 34 ) havingtangs 452A, 452B, for example. Rather, breakoff screw 450, to the extentincluded, may include a continuous cylindrical shaped aperture 452Zwithout the discontinuity. In some embodiments, a similar screw may beused that is not a breakoff screw but rather may be referred to as alocking screw. Additionally, in this embodiment, implant 400Z mayinclude a first gripping indentation 419Z and a second grippingindentation 429Z (see FIG. 42A) in lieu of the gripping protrusions 419,429 (as shown in FIG. 33 ), for example. In various embodiments, firstgripping indentation 419Z may be formed as a part of the superiorendplate 410 and second gripping indentation 429Z may be formed as apart of the inferior endplate 420, for example.

In various embodiments, gripping indentations 419Z, 429Z may includevarious types of contouring to facilitate coupling with a correspondingsurgical tool 600. In this embodiment, gripping indentations 419Z, 429Zeach comprise a slotted indentation extending in a proximal to distaldirection with a curved superior surface 419S, 429S and a curvedinferior surface 4191, 4291. Additionally, gripping indentations 419Z,429Z each have an open channel portion 419X, 429X adjacent the breakoffscrew 450, to the extent a breakoff screw is included. As will beexplained in further detail below, corresponding gripping protrusions ofa surgical tool 600 may have a substantially similar size and shape tothe gripping indentations 419Z, 429Z, for example.

FIGS. 43A-43B illustrate a similar embodiment as FIGS. 42A-42B. Asshown, the implant 400Z includes angled engagement features 14. In theexample embodiment, engagement features 14 extend diagonally across theexposed uppermost surface of superior endplate 410 and across theexposed lowermost surface of inferior endplate 420. The engagementfeatures 14 comprise flattened top rails that are sequentially spacedapart with rounded bottom valleys 14V therebetween. As seen best in thetop-down view of FIG. 43B, the engagement features 14 of the superiorendplate 410 are oriented at an angle β with respect to a proximal face410F of the superior endplate 410. Similarly, the engagement features 14of the inferior endplate 420 are oriented at an angle β with respect toa proximal face 420F of the inferior endplate 420 (see FIG. 43A). Invarious embodiments, the angle β may be about 20-40 degrees and in atleast one embodiment the angle β may be angled at about 30 degrees. Atleast one advantage of this orientation may be a relatively greaterresistance and/or suppression of expulsion of the implant 400Z relativeto embodiments in which engagement features solely extend horizontallyacross the implant 400Z. In the example embodiment of FIGS. 43A-43B, byorienting the engagement features 14 diagonally, the implant 400Z mayresist expulsion in multiple directions, e.g., forward flexion/extensionand lateral bending.

Referring generally to FIGS. 44-48 , various views of a surgical tool600 are disclosed. FIG. 44 illustrates the surgical tool 600 coupled toimplant 400Z. FIG. 44 is a perspective view of surgical tool 600; FIG.45 is a first side view of surgical tool 600; and FIG. 46A is a secondside view of surgical tool 600. FIG. 46B is a third side view ofsurgical tool 600 in an operative position and FIG. 46C is a perspectiveview of surgical tool 600 in the operative position of FIG. 46B. FIG.47A is an exploded parts view of surgical tool 600 with select partsremoved for ease of understanding and FIG. 47B is an exploded parts viewof surgical tool 600 showing additional detail and parts. FIG. 48illustrates surgical tool 600 immediately prior to coupling with implant400Z. In the example embodiment, tool 600 may serve several purposes.For example, tool 600 may be used to insert implant 400Z, expand implant400Z, and in some embodiments may also rotate breakoff screw 450 tocause it to separate into two portions along breakoff location 455 (seeFIG. 34 ).

With reference to the perspective view of FIG. 44 and the exploded partsviews of FIGS. 47A and 47B, tool 600 may include a gripping handle 601that is securely coupled to first body portion 607. First body portion607 may rotatably support an inner shaft 606 and an outer shaft 602therein. Shafts 606, 602 may extend through aperture 607A of first bodyportion 607 in a longitudinal direction from a proximal end to a distalend. The inner shaft 606 may be securely connected to turn knob 603 at aproximal end 600P and the outer shaft 602 may be securely connected toturn handle 604 at the proximal end 600P. The inner shaft 606 may extendthrough outer shaft 602 and include a thread pattern 606T at a distalend thereof for securely connecting to corresponding threads 456 ofbreakoff screw 450 (see FIG. 42B for example). The inner shaft 606 maybe independently rotatable relative to outer shaft 602 by rotating turnknob 603. Additionally, the outer shaft 602 may be independentlyrotatable relative to inner shaft 606 by rotating turn handle 604, forexample. Generally, both the inner shaft 606 and outer shaft 602 willinteract with and/or couple to breakoff screw 450 as will be explainedin further detail below.

With reference to FIGS. 45 and 46A-46C, tool 600 may include an actuator605 in the form of a trigger that is connected to first body portion 607at pin 605C. Actuator 605 may be actionable to expand implant 400Z bypivoting a linkage assembly 608 including first arm 610 and second arm611 relative to a third fixed arm 620, for example. Second arm 611 maybe coupled to actuator 605 via pin 605B such that pin 605B may belinearly translatable forward and backward in a proximal-to-distaldirection within slotted aperture 605A. In turn, second arm 611 may becoupled to first arm 610 via pin 610B such that second arm 611 may pivotup and down. Additionally, first arm 610 may be coupled to third arm 620and in various embodiments third arm 620 may be fixed relative to firstbody portion 607. Additionally, third arm 620 may include a protrusion620B which may be slidably seated within a curved vertical slot, forexample slot 610A, and thereby guide motion of arm 610 as it pivots upand down. As seen best in FIGS. 46B and 46C, depressing actuator 605 maycause linkage assembly 608 to pivot by causing second arm 611 to movedistally such that first arm 610 pivots relative to third arm 620 andimplant 400Z may be expanded.

With reference back to FIG. 44 , third arm 620 may include an apertureextending therethrough in a proximal to distal direction foraccommodating a linearly translatable shaft 621. Shaft 621 mayindependently move forward and backward in a proximal to distaldirection within the through aperture 624 of third fixed arm 620 (seeFIGS. 47A and 47B), for example. Shaft 621 may include a charging handleat a proximal end thereof allowing an end user to manipulate shaft 621in a forward and backward motion (proximal motion and distal motion inthe proximal-to-distal direction). In some embodiments, an end user maytranslate charging handle 622 rotatably in a clockwise orcounterclockwise motion, for example to lock shaft 621 in a relativeposition. Additionally, in some embodiments, when shaft 621 is not in alocked position, depressing actuator 605 will not expand implant 400Zfor reasons explained in more detail below.

With reference to FIG. 48 , first arm 610 may include a gripping outdent619 having a size and shape generally corresponding to a size and shapeof gripping indentation 419Z. Additionally, first arm 610 may include acounter torque surface 615 having a size and shape generallycorresponding to a size and shape of the proximal surface of thesuperior endplate 410, for example. Similarly, shaft 621, extendingthrough fixed arm 620, may include a gripping outdent 629 having a sizeand shape generally corresponding to a size and shape of grippingindentation 429Z (as shown in FIG. 42A). Additionally, second arm 620may include a counter torque surface 625 having a size and shapegenerally corresponding to a size and shape of the proximal surface ofthe inferior endplate 420, for example. In this way, when shaft 621 ismoved distally such that the outdent 629 is seated within indent 429Zand outdent 619 is seated within indentation 419Z (as shown in FIG. 42A)an end user may activate actuator 605 to expand implant 400Z whilesurfaces 615, 625 resist a twisting motion of implant 100. For example,as shown in FIGS. 46B and 46C an end user may depress actuator 605 bysqueezing the trigger which in turn may cause the linkage assembly 608to pivot the first arm 610 relative to fixed arm 620 such that tool 600may urge the superior endplate 410 and inferior endplate 420 away fromone another.

With reference to the cross-section drawings of FIGS. 49, 50, and 51additional features and functionality of tool 600 will be explained. InFIGS. 49 and 50 , it is shown that the threaded end of inner shaft 606is threadably engaged with the threaded aperture 456 of breakoff screw450. Additionally, a proximal drive feature 453A is mated within acorresponding female drive feature 602A (see FIG. 48 ) at the distalmost end of outer shaft 602. As explained previously, inner shaft 606and outer shaft 602 are independently operable. In use, an end user mayinitially position inner shaft 606 adjacent to/within the front portionof threaded aperture 452 and rotate inner shaft 606 via turn knob 603.As inner shaft 606 is rotated, implant 400Z is pulled towards tool 600.FIGS. 49-51 show implant 400 after inner shaft 606 has been sufficientlyrotated such that implant 400Z abuts the counter torque surfaces 615,625 and the gripping protrusion 619 may be seated within thecorresponding gripping indentation 419Z. With reference to FIG. 51 ,once implant 400Z is pulled sufficiently towards tool 600, an end usermay actuate shaft 621 by pushing on charging handle 622 to overcome thebiasing force of spring 623 such that gripping protrusion 629 may beseated within the corresponding gripping indentation 429Z, for example.In some embodiments, an end user may rotate charging handle 622 suchthat biasing force of spring 623 is prevented from urging shaft 621 awayfrom implant 400Z. At this point, the implant 400Z may be in anoperatively engaged position with tool 600.

Once implant 400Z is in the operatively engaged position, an end usermay insert implant 400Z into a disc space between a superior vertebraand inferior vertebra (cephalad vertebra and caudal vertebra), forexample. After the implant 400Z is positioned between the superior andinferior vertebrae, an end user may depress actuator 605 thereby causingthe linkage assembly 608 to pivot and spread the superior endplate 410apart from the inferior endplate 420. Once the end user has expandedimplant 400Z to an appropriate position, the end user may rotate turnhandle 604 which will rotate breakoff screw 450 via first drive feature453A. The end user may continue to rotate breakoff screw 450 such thatit advances into implant 400Z in a proximal to distal direction andlocks implant 400Z in the expanded configuration similarly as explainedabove. The end user may continue to rotate turn handle 604 until thetorque applied to breakoff screw 450 is great enough that the breakoffscrew 450 will shear into two pieces similarly as explained above.Notably, the broken off or sheared off portion of breakoff screw 450 maybe retained by tool 600 on account of inner shaft 606 being threadablycoupled to threaded aperture 452.

With reference to the perspective views of FIGS. 52 and 53 and theexploded parts view of FIG. 54 , a surgical tool 700 is disclosed.Surgical tool 700 may be used to insert any of the various implantembodiments disclosed herein into a disc space and expand the implant.Additionally, surgical tool 700 may be used to lock various implantembodiments in an angled configuration after the implant has beenexpanded. Surgical tool 700 may include an inserter portion 701 forgripping, inserting, and expanding an implant and a drive portionconfigured for disposal within the inserter portion 701 for locking theimplant in an expanded position. Drive portion 702 may be disposedwithin the hollow shaft of the inserter portion and may include a driveactuator 750 and a drive shaft 755 having a drive end 760. Inserterportion 702 may include a rotation knob handle 740 that is threadablyengaged with or operatively coupled with a gear rack 720 having athreaded tube on the proximal gear rack end 723. In the exampleembodiment, gear rack tube 730 is operatively coupled with cam shaft 725and is coaxially positioned within a tube of the proximal gear rack end723.

Cam shaft 725 may include a plurality of cam shaft lobes 728 protrudingtransverse from a longitudinal direction of the shaft 725 that may bedisposed in the distal portion of cam shaft 725. In various embodiments,the number of cam shaft lobes 728 may be about 4-6 and in others theremay be about 2 to about 10. Those with skill in the art will recognizethat the number of cam shaft lobes 728 may vary. In some embodiments,the cam shaft lobes 728 and the cam shaft 725 may be formed by a unitarypiece, e.g., they may be monolithically formed. In other embodiments,the cam shaft lobes 728 may be modularly integrated as needed on thedistal portion of cam shaft 725. In various embodiments, the cam shaftlobes 728 may be protruding at about 180° offsets from each other in thelateral directions.

In the example embodiment, non-rotating jaw 705 may be secured and incontact with a lateral side of the distal end of gear rack 720 and thecam shaft lobes 728. Rotating jaw slide 710 and rotating jaw 715assembly are secured and in contact with opposite lateral sides of thecam shaft lobes 728. In various embodiments, drive shaft 755 includes adrive end 760 that may coaxially extend through a respective centralaperture of rotation knob handle 740, proximal gear rack end 723, gearrack tube 730, and cam shaft 725 in a longitudinal direction from aproximal end to a distal end. The drive shaft 755 may be operativelyconnected to a drive actuator 750 at the proximal end 700P for rotatingthe drive shaft 755. In various embodiments drive actuator 750 may be aT-shaped handle. Drive shaft 755 may include a drive end 760 disposed ata distal end of the surgical tool 700 for securely connect to acorresponding locking screw drive feature 453B. In various embodiments,the drive shaft 755 may include a drive end 760 having a size and shapecorresponding to a size and shape of drive feature 453B (see FIG. 32 ).In various embodiments, the inner drive shaft 755 may be independentlyrotatable relative to outer gear rack tube 730 and cam shaft 725 byactivating the drive actuator 750. Additionally, the cam shaft 725 maybe rotatable relative to inner drive shaft 755 by cam twist grip 727which may be securely coupled to cam shaft 725 by cam shaft pins 726.Generally, both the inner drive shaft 755 and outer cam shaft 725 willinteract with and/or couple to implant 400Z as will be explained infurther detail below.

With reference to FIG. 55 and the exploded parts views of FIGS. 56-58 ,inserter portion 701 of surgical tool 700 may include: a distal endcomprising a non-rotating jaw 705 having an end 706 for gripping animplant, and a rotating jaw 715 having an end 716 for gripping animplant that is coupled to a rotating jaw slide 710. In variousembodiments, the non-rotating jaw 705 and rotating jaw 715, together asa pair, may be referred as “parallel jaws” which may grip and expandcorresponding portions of an intervertebral spinal implant.Additionally, the non-rotating jaw end 706 and rotating jaw end 716 mayeach include female recesses having a size and shape generallycorresponding to a size and shape of gripping protrusions 429, 419 ofimplant 400 (see FIG. 31 ). Rotating Jaw 715 may be operatively coupledwith rotating jaw gear 717 which allows for the rotating jaw 715 to movein a vertical direction (represented by arrow in FIG. 55 ) along theinner gear thread of rotating jaw 715. Additionally, rotating jaw gear717 is meshed with distal dial indicator gear 739, which is operativelycoupled to distal gear rack teeth 721 on gear rack 720, such that whenrotation knob handle 740 is rotated the rotating jaw gear 717 and distaldial indicator gear 739 are simultaneously activated. In this way, eachincremental movement of rotation knob handle 740 causes a correspondingincremental movement of the dial indicator gear 739 such that throughoutthe entirety of an expansion process a surgeon knows exactly what angleof inclination the implant is in (e.g., lordosis). In variousembodiments, distal dial indicator gear 739 may have a suitable diameterand number of teeth that are coordinated with respect to an implanthaving a particular size. For example, in the example embodiment, distaldial indicator gear 739 may be smaller than rotating jaw gear 717.

In the example embodiment shown in FIG. 58 , twist grip 727 may beactionable to rotate clockwise and counterclockwise along the A1rotation axis. Rotation thereof may effectuate the opening ofnon-rotating jaw 705 and rotating jaw 715 for gripping of the implant.For example, rotation of twist grip 727 may rotate the cam shaft 725 inthe corresponding Ala direction such that the cam shaft lobes 728laterally push rotating jaw 715 in a horizontal direction S1 away fromnon-rotating jaw 705. For example, by moving one of the jaws away fromthe other jaw, or even by moving both of the jaws away from one another.In various embodiments, the cam shaft lobes 728 may provide bilateralcontact with non-rotating jaw 705 and rotating jaw slide 710 toprecisely control the horizontal position. In some embodiments, the camshaft lobes 728 are configured so that the “open” and “closes” jaworientations are in a lock step with the orientation of the cam shaft725. By moving the jaws apart from one another a horizontal distancebetween the two jaws is increased and an implant may be positionedbetween the two jaws for coupling to the jaws once the jaws are closedback together. In the “open jaw” orientation, gripping protrusions 419,429 of implant 400 may be positioned horizontally in-line with thenon-rotating jaw end 706 and rotating jaw end 716 such that the paralleljaws may be subsequently closed to the original position. For example,by rotating the cam twist grip 727 to retract the non-rotating jaw 705and rotating jaw 715 to a “closed jaw” orientation thereby securelycoupling surgical tool 700 with implant 400. In this way, the grippingprotrusion 419 on superior endplate of implant 400 may be coupled withrotating jaw end 716 and the gripping protrusion 429 on inferiorendplate of implant 400 may be coupled with non-rotating jaw 706 (seeFIG. 31 showing implant). In the example embodiment, the dovetailrecesses of jaw ends 706, 716 may mate with the dovetail grippingprotrusions 419, 429 of implant. In various embodiments, the recess ofrotating jaw end 716 may be larger than a recess of non-rotating jaw end706. This may help ensure the implant is mated to the surgical tool in aproper orientation, e.g., it isn't mated in reverse. In someembodiments, rotating jaw end 716 may be coupled to gripping protrusion419 on the superior endplate of implant 400 and non-rotating jaw end 706may be coupled to gripping protrusion 429 on the inferior endplate ofimplant 400.

With reference to FIG. 59 , once implant 400 is securely coupled withthe surgical tool 700 via non-rotating jaw end 706 and rotating jaw end716, the rotating jaw 715 may be translated vertically to expand theimplant. In various embodiments, actuation of the rotation knob handle740 may rotate the rotating jaw gear 717. As seen in FIG. 59 , rotationknob handle 740 may be actionable to rotate along the A2 axis whichtranslates gear rack 720 in a longitudinal direction L1 (see FIG. 59 ).In turn the translated gear rack 720 activates and rotates distal dialindicator gear 739 along distal gear rack teeth 721 which, in turn,activates the rotating jaw gear 717 that is coupled to distal dialindicator gear 739 by gear shaft 718 and translates the rotating jaw 715in a vertical V1 direction. In this way, surgical tool 700 may causepivoting of the superior endplate 410 of implant 400 along a hingemember 440 of the inferior endplate 420. For example, by lifting up onthe superior endplate 410 via rotating jaw 715 the implant 400 mayexpand into an angled configuration because of the pivoting hinge typeconnection.

With reference to FIG. 59 and FIG. 60 , when rotation knob handle 740 isrotated along rotation axis A2, the proximal gear rack teeth 722 anddistal gear rack teeth 721 of the gear rack 720 are translatedlongitudinally in the L1 direction thereby simultaneously rotating eachof the three proximal dial indicator gears 738 and the distal dialindicator gear 739. Additionally, in this embodiment distal dialindicator gear 739 is coupled to rotating jaw gear 717 via gear shaft718 (see FIG. 59-60 ). In this way rotation of gears 717 and 739translates the rotating jaw 715 vertically in the V1 direction therebyexpanding the implant 400. In this embodiment, three proximal dialindicator gears 738 are individually attached to respective dial angleindicators for visually identifying and verifying an angle ofinclination of a correspondingly sized implant 400. The respective dialindicators each identify the angle of inclination for a differentlysized implant 400. In the example embodiment, three dial indicators areprovided: a large dial angle indicator 737, a medium dial angleindicator 736, and a small dial angle indicator 735 although any numberof indicators may be provided. Consistent with the disclosure herein,implants 400 of various sizes may be used depending on patient specificanatomy and the intended use case. The configuration of three differentdial indicator gears 738 allows a surgeon to know the angle ofinclination of any of the three differently sized implants. For example,the same relative movement of rotation knob handle 740 may causedifferent amounts of expansion and angulation for implants of differentsizes, e.g., small, medium, large, and the disclosed surgical tool 700can be used interchangeably with any of these differently sizedimplants.

With reference to FIGS. 61-64 , four different configurations fornon-rotating jaw 705 and rotating jaw 715 are disclosed. FIG. 61 showstwo parallel jaws in a closed position where the jaws are closertogether and with rotating jaw 715 in a down position (neutralposition). FIG. 62 shows the parallel jaws in a closed position wherethe jaws are closer together and with rotating jaw 715 in an up positionfor expanding the implant. FIG. 63 shows the parallel jaws in an openposition where the jaws are farther apart for coupling to an implant andwith rotating jaw 715 in a down position. FIG. 64 shows the paralleljaws in an open position where the jaws are farther apart for couplingto an implant and with rotating jaw 715 in an up position.

With reference to FIGS. 65A and 65B, the interaction between the driveportion and the inserter portion of surgical tool 700 will be discussed.As explained previously, drive portion 702 may be inserted within acentral aperture extending in the longitudinal direction of inserterportion 701 such that the drive portion 702 may interact with thelocking screw of implant 400Z. In the example illustration, proximal endof drive shaft 755 is securely coupled to drive actuator 750. Driveshaft 755 extends longitudinally through the apertures of rotation knobhandle 740, proximal gear rack end 723, gear rack tube 730, and camshaft 725 such that end 760 is disposed between the parallel jaws. Thisconfiguration allows a surgeon to expand implant 400Z and rotate thelocking screw 50 of implant 400Z while it is expanded.

A method of operation for expanding an intervertebral implant to adesired angle of inclination will now be discussed. First, a surgeon maysecurely couple an intervertebral implant 400Z to surgical tool 700.Once implant 400Z is in the operatively engaged position with surgicaltool 700, i.e., parallel jaws side by side in a closed position, asurgeon may insert implant 400Z into a disc space of a patient between asuperior (cephalad) vertebra and inferior (caudal) vertebra, forexample. After the implant 400Z is positioned between the superior andinferior vertebrae, the surgeon may rotate rotation knob handle 740along the A2 axis thereby separating the superior endplate 410 apartfrom the inferior endplate 420, e.g., by translating the rotating jaw715 vertically relative to the non-rotating jaw 705. In variousembodiments, depending on the size of implant 400, the expanded anglemay be identified by one of large dial angle indicator 737, medium dialangle indicator 736, or small dial angle indicator 735.

A method of locking an intervertebral implant in a desired angle ofinclination will now be discussed. With the implant 400Z positioned andexpanded appropriately in the disc space the surgeon may lock thesuperior endplate 410 and inferior endplate 420 in the desiredconfiguration while surgical tool 700 maintains the intervertebralimplant at a particular lordotic angle. At this stage, the surgeon mayinsert the drive portion 702 into the inserter portion 701 if they arenot otherwise already together. It shall be understood that in someembodiments the drive portion 702 may remain in the inserter portion 701throughout the insertion and expansion steps discussed above in thepreceding paragraph. Next, the surgeon may verify that drive end 760 ismatingly positioned in a corresponding drive end of the locking screw50. Thereafter, the surgeon may activate the drive actuator 750 (rotatethe T-shaped handle) to rotate drive shaft 755 along rotation axis A3thereby rotating the drive end 760 and locking screw 50 because of theway drive feature 453B is engaged with drive end 760. For example, driveend 760 is rotated along axis A3 a thereby causing rotation of thelocking screw 50. In some embodiments, the non-rotating jaw 705 havingan end 706 coupled to the gripping protrusion 429 on the inferiorendplate of implant 400 may provide a two-part connection that resistsrotation of the implant along a longitudinal axis of the drive shaftwhen drive end 760 provides rotational forces to actuate the rotation ofthe locking screw 50. The surgeon may continue to rotate the drive shaft755 and the locking screw 50 until it advances sufficiently far enoughinto implant 400Z and locks the implant 400Z in an expandedconfiguration as explained previously. In some embodiments, driveportion 702 may include a torque limiting feature to ensure that thelocking screw 50 is tight enough to hold the implant in the lockedconfiguration but not too tight that shearing might occur. Once implant400Z is inserted and opened to the desired configuration and locked, thedrive shaft 755 may be disengaged from implant 400Z by removing driveactuator 750 and drive shaft 755 back through the aperture of rotationknob handle 740, proximal gear rack end 723, gear rack tube 730, and camshaft 725 in a longitudinal direction from a distal end to a proximalend. Finally, the surgeon may rotate the cam twist grip 727 tohorizontally open the non-rotating jaw 705 and rotating jaw 715laterally away from one another in the S1 direction (see FIG. 58 ) todisengage from gripping protrusions 419, 429 of implant 400 and removethe inserter portion 701 of the surgical tool 700. Those with skill inthe art will appreciate that the spreading of the parallel jawslaterally away from one another vs. vertically away from one another iscritical to prevent the jaws from contacting delicate patient tissue orbeing obstructed by the adjacent superior and inferior vertebra duringthe uncoupling process.

Unless otherwise specifically defined herein, all terms are to be giventheir broadest possible interpretation including meanings implied fromthe specification as well as meanings understood by those skilled in theart and/or as defined in dictionaries, treatises, etc. It must also benoted that, as used in the specification and the appended claims, thesingular forms “a,” “an” and “the” include plural referents unlessotherwise specified, and that the terms “comprises” and/or “comprising,”when used in this specification, specify the presence of statedfeatures, elements, and/or components, but do not preclude the presenceor addition of one or more other features, steps, operations, elements,components, and/or groups thereof.

What is claimed is:
 1. A surgical tool for manipulating an expandableintervertebral implant, comprising: an inserter configured to couple toand uncouple from an intervertebral implant, the inserter extendinglengthwise in a longitudinal direction from a proximal end to a distalend, widthwise in a horizontal direction transverse to the longitudinaldirection, and heightwise in a vertical direction transverse to thelongitudinal direction and the horizontal direction, the insertercomprising: an outer body assembly for supporting a first actuator and asecond actuator; a first jaw and a second jaw disposed at the distal endof the inserter and being configured to couple to and uncouple from afirst endplate and a second endplate of the expandable intervertebralimplant, respectively; wherein the first jaw is configured to couple toa first gripping protrusion on first endplate; wherein the second jaw isconfigured to couple to a second gripping protrusion on second endplate;wherein the first jaw comprises a first gripping indent having a sizeand shape corresponding to the first gripping protrusion and the secondjaw comprises a second gripping indent having a size and shapecorresponding to the second gripping protrusion; wherein the firstactuator is configured to spread the first jaw and the second jaw apartin the horizontal direction for coupling to the first endplate and thesecond endplate; and wherein the second actuator is configured to spreadthe first jaw and the second jaw apart in the vertical direction forpivotally expanding the intervertebral implant.
 2. The surgical tool ofclaim 1, further comprising: a rack extending in the longitudinaldirection and including teeth, the rack being operatively coupled to thefirst actuator; and a first gear meshed with the teeth of the rack and asecond gear meshed with teeth of the first jaw, wherein the rack isconfigured to move forward and backward in the longitudinal directionupon actuation of the first actuator thereby rotating the first gear andsecond gear and moving the first jaw away from the second jaw in thevertical direction.
 3. The surgical tool of claim 2, further comprising:at least one indicator gear meshed with the teeth of the rack and beingconfigured to rotate upon movement of the rack in the longitudinaldirection; and wherein the at least one indicator gear is coupled to acorresponding indicator configured to visually display an angle ofinclination measured between the superior endplate and the inferiorendplate.
 4. The surgical tool of claim 2, wherein the first gear andthe second gear are rigidly coupled together by a shaft.
 5. The surgicaltool of claim 2, further comprising: a cam shaft operatively coupled tothe second actuator and including a plurality of lobes protrudingtherefrom; wherein the lobes provide bilateral contact with arms of thefirst jaw and the second jaw thereby precisely controlling theirhorizontal positions; and wherein actuation of the second actuatorrotates the cam shaft thereby spreading and closing the first jaw andthe second jaw apart in the horizontal direction.
 6. The surgical toolof claim 5, further comprising a slide operatively coupled to the firstjaw and the cam shaft.
 7. The surgical tool of claim 1, furthercomprising: a drive tool configured to be removably disposed within acentral hollow shaft of the inserter, the drive tool including a driveshaft extending from a proximal end to a distal end, the distal endincluding a drive portion configured to engage with a rotatable screwthat when rotated is configured to maintain the superior endplate andthe inferior endplate in the expanded position; wherein the second jawcoupled to the second protrusion and the drive portion coupled to therotatable screw provide a two-part connection that resists rotation ofthe expandable intervertebral implant along a longitudinal axis of thedrive shaft when the first jaw expands or closes the expandableintervertebral implant.
 8. A system including an intervertebral implantand a surgical tool, the system comprising: an expandable implantmovable between a contracted position and an expanded position, theexpandable implant comprising: an expandable body extending from aproximal end to a distal end in a proximal-to-distal direction andextending from a first lateral side to a second lateral side in awidthwise direction, the expandable body being defined by a superiorendplate and an inferior endplate that are hingedly connected; thesuperior endplate comprises a first core having screw slot and a distalengagement surface; the inferior endplate comprises a second core havinga proximal engagement surface; and a locking screw movable between alocked position and an unlocked position; a surgical tool configured formoving the expandable implant from the contracted position to theexpanded position and for rotating the locking screw between the lockedposition and the unlocked position, the surgical tool being configuredto simultaneously rotate the locking screw into the locked positionwhile supporting the expandable implant in the expanded position, thesurgical tool comprising: an inserter portion configured to couple toand uncouple from the expandable implant, the inserter portion having anouter body assembly, a rotation knob handle, a cam twist grip, and anon-rotating jaw and a rotating jaw configured to expand the expandableimplant, wherein a hollow shaft extends longitudinally through theinserter portion; and a drive portion disposed within the hollow shaftof the inserter portion, the drive portion having a drive shaftextending from a proximal end to a distal end, the distal end includinga drive portion configured to engage with the locking screw, and theproximal end including a drive actuator for rotating the drive shaft,wherein actuation of the rotation knob handle spreads the rotating jawand non-rotating jaw apart from one another in a vertical directionthereby pivotally expanding the expandable implant, and whereinactuation of the cam twist grip spreads the rotating jaw andnon-rotating jaw apart from one another in a horizontal directiontransverse to the vertical direction.
 9. The system of claim 8, wherein:the superior endplate comprises a first gripping protrusion located at aproximal end thereof and the inferior endplate comprises a secondgripping protrusion located at a proximal end thereof, and thenon-rotating jaw comprises a first gripping indent having a size andshape corresponding to the first gripping protrusion and the rotatingjaw comprises a second gripping indent having a size and shapecorresponding the second gripping protrusion.
 10. The system of claim 9,wherein the first gripping protrusion and the first gripping indentcomprise a first dovetail connection, and the second gripping protrusionand the second gripping indent comprise a second dovetail connection.11. The system of claim 10, wherein the surgical tool further comprises:a gear rack coupled to the rotation knob handle and being configured tomove forward and backward along a longitudinal axis to thereby spreadthe rotating jaw away from the non-rotating jaw upon rotation of therotation knob handle, the gear rack including teeth at a proximal endthereof and teeth at a distal end thereof; and at least one dialindicator gear meshed with the teeth of the proximal end of the gearrack, wherein the at least one dial indicator gear is coupled to acorresponding indicator configured to visually display an angle ofinclination measured between the superior endplate and the inferiorendplate.
 12. The system of claim 11, further comprising: a first distalgear supported by the non-rotating arm and being meshed with the teethof the distal end of the gear rack; and a second distal gear meshed witha rack portion of the rotating jaw, wherein rotation of rotation knobhandle causes the second distal gear to rotate thereby moving therotating jaw in a vertical direction.
 13. The system of claim 12,wherein the first distal gear and the second distal gear are connectedby a shaft.
 14. The system of claim 11, wherein the surgical toolfurther comprises: a gear rack tube operatively coupled to a cam shaft,the cam shaft comprising a plurality of lobes protruding therefrom; anda cam shaft having an aperture extending therethrough coupled at adistal end of the gear rack tube, wherein the cam shaft is operativelycoupled to the cam shaft twist grip.
 15. The system of claim 14, whereinthe cam shaft lobes are disposed along a distal half of the cam shaftand are configured to push the rotating jaw in the horizontal directionupon rotation of the cam shaft.
 16. The system of claim 15, wherein thecam twist grip is fixedly coupled at a center region of the cam shaft bycam shaft pins.
 17. The system of claim 16, wherein the surgical toolfurther comprises: a slide operatively coupled to the rotating jaw, theslide being coupled to the distal half of the cam shaft; and wherein thenon-rotating jaw is coupled to the distal half of the cam shaft oppositethe slide.
 18. The system of claim 13, wherein: the rotating jaw end isconfigured to engage with the gripping protrusion on the superiorendplate; the non-rotating jaw end is configured to engage with thegripping protrusion on the inferior endplate; and the rotation knobhandle is configured to translate the rotating jaw in the verticaldirection thereby separating the superior endplate from the inferiorendplate at a hinge member of the inferior endplate and expanding theexpandable implant.
 19. The system of claim 8, wherein: the lockingscrew is threadably engaged with the inferior endplate, and the driveportion is configured to rotate the locking screw thereby urging thedistal engagement surface of the first core against the proximalengagement surface of the second core.
 20. The system of claim 8,wherein the drive portion is removably disposed within the hollow shaftof the inserter portion.